DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K102865
• Device Name: DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
• Date Cleared: 2010-11-03 ( 34 days)
• Product Code: ITX , IYN , IYO
• Regulation Number: 892.1570
• Type: Special
• Panel: Radiology
• Reference & Predicate Devices: K101041 , K091941 , K102991
• Predicate For: N/A

Intended Use

The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams.

Device Description

The DC-3/DC-31 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, PW mode, Power mode, DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

AI/ML Overview

The provided text is a 510(k) summary for the Mindray DC-3/DC-3T Diagnostic Ultrasound System. It is a declaration of substantial equivalence to previously cleared devices, rather than a study outlining acceptance criteria and device performance. As such, the input does not contain the information needed to directly answer all parts of your request.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary, which a regulatory submission to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This type of submission does not typically include a table of acceptance criteria or quantitative performance metrics from a specific study designed to prove the device meets these criteria. Instead, it asserts equivalence based on technological characteristics and adherence to safety standards.

2. Sample Size Used for the Test Set and Data Provenance:

No studies with a "test set" are described, nor is there information about sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) relies on comparison to existing predicate devices and compliance with recognized standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since no specific study evaluating the device's diagnostic performance against a ground truth is described, there is no information on the number or qualifications of experts used for establishing ground truth.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as no specific test set-based study is presented.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is described in this 510(k) summary. The document focuses on establishing substantial equivalence based on technological characteristics and adherence to safety standards, not on demonstrating improved human reader performance with AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This device is a general-purpose diagnostic ultrasound system, not an AI-powered algorithm. Therefore, a standalone algorithm-only study is not applicable and not mentioned. The declaration is for the complete ultrasound system.

7. The Type of Ground Truth Used:

No ground truth is mentioned as no specific diagnostic performance study is presented. The "ground truth" in a 510(k) for a general ultrasound system is typically considered to be compliance with established safety and performance standards for diagnostic ultrasound and equivalence to predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a traditional ultrasound system, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as (8).

Summary of available information from the document:

• Acceptance Criteria/Performance: The submission claims the device "has been found to conform with applicable medical safety standards" (UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1, and IEC 62304) and is "substantially equivalent" to predicate devices (Mindray DC-7(K101041), Mindray DC-3/DC-3T (K091941) and Mindray M5(K102991)). This implies that the 'acceptance criteria' are primarily regulatory compliance and demonstration of equivalence to existing devices.
• Study Design: This is a 510(k) summary, which is a regulatory submission asserting substantial equivalence, not reporting a clinical study with detailed performance metrics. It does not describe a clinical study in the format one might expect for device performance evaluation against specific metrics.
• Intended Use: The device is broadly applicable for adults, pregnant women, pediatric patients, and neonates for various exams including gynecology, obstetrics, abdominal, cardiac, vascular, and small parts.
• Transducers: A list of compatible transducers (3C5A, 6C2, 7L5, 6CV1, 6LE7, 7LT4, 7L4A, 6LB7, D6-2, 7L6, 3C1, 10L4, 2P2) is provided, each with specific "Indications for Use" forms detailing the clinical applications and modes of operation they support. "P" indicates previously cleared by FDA for that application/mode.

Summary

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NOV -

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building. Keji 12th Road South, Hi-tech Industrial Park, Nanshan. Shenzhen, 518057. P. R. China

Tel: [phone] Fax: [phone]

Contact Person:

Zhai Pei Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: September 27, 2010

2. Device Name:

DC-7 Diagnostic Ultrasound System DC-3/DC-3T Diagnostic Ultrasound System

Classification

Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Device Description:

The DC-3/DC-31 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, PW mode, Power mode, DirPower

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mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

4. Intended Use:

The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams.

5. Comparison with Predicate Device:

DC-3/DC-3T Diagnostic Ultrasound System is comparable with and substantially equivalent to the Mindray DC-7(K101041), Mindray DC-3/DC-3T (K091941) and Mindray M5(K102991) Diagnostic Ultrasound System. They have the same technological characteristics. are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device.

6. Non-clinical Tests:

DC-3/DC-3T Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2, UD 3.IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37 ,IEC 60601-1-4 ,ISO 10993-1 and IEC 62304.

Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-3/DC-37 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021

NOV - 3 2010

Re: K102865

Trade/Device Name: DC-3/DC-3T Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: September 30, 2010 Received: September 30, 2010

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the DC-3/DC-3T Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3C5A	6C2	7L5
6CV1	6LE7	7LT4
7L4A	6LB7	D6-2
7L6	3C1
10L4	2P2

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Paul Hardy at [phone].

Sincerely yours,

Signature

David G. Brown. Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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							Device Name: DC-3/DC-3T Diagnostic Ultrasound System
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Dlagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Dingnostie Ultrasound System nia

Transcucer: Intendod Use;

Sustern:

Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
General(Track 1 Only)	Specific(Track 1 & 3)
Ophthalmic	Ophthalmic	P	P	P	P	P	P	Note 1,2,3,4,5,6,7
FetalImaging& Other	Fetal	P	P	P	P	P	P	P	Note 1,2,3,4,5,6,7
	Abdominal	P	P	P	P	P	P	P	Note 1,2,3,4,5,6,7
	Intraoperative (specify)*	P	P	P	P	P	P	P	Note 2,3,4,5,6
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5,6,7
	Small organ(specify)**	P	P	P	P	P	P	P	Note 2,3,4,5,6
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,3,5,6
	Trans-rectal	P	P	P	P	P	P	P	Note 2,3,4,5,6
	Trans-vaginal	P	P	P	P	P	P	P	Note 2,3,5,6
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletalConventional	P	P	P	P	P	P	P	Note 2,3,4,5,6
	Musculo-skeletalSuperficial	P	P	P	P	P	P	P	Note 2,3,4,5,6
	Intravascular
	Other (specify)***	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
	Other (specify)

new indication; Papreviously cizared by FDA; E=added under Appendix E

Addisonal comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + P.W +B.

• ·Intraoperative includes abdominal, theracic, and vascular etc.
• • Small organ-breast, thyroid, testes, etc.
• ** *Other use includes Urology. Note I: Tizsue Harmonie Imaging.
• Note 2; SmarlJD
• Note 3: iScape
• Noter: iBeam
• Notes: Biopsy Quidar

Notes: Frec Xros M

Note?: 4D

STOK

Prescription USE (Per 2

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

0030

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Diagnostic Ultrasound Indications for Use Form

System: Transduccr:

DC-3/DC-3T Diagnostic Ultrasound System 3C5A

Intended Use:

Diagnostic altrasound imaging or fluid flow analysis of the turnan body as follows:

	Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1, 2, 3,5,6
	Abdominal	P	P	P		P	P	P	Note 1, 2, 3,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,5,6
	Small organ(specify)**
FetalImaging& Other.	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***	P	P	P		P	P	P	Note 1,2,3,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	P	P	P		P	P	P	Note 1, 2, 3,5,6
	Other (specify)

Additional compens: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Pow

• Intraoperative includes abdominal, thorneie, sod vascular etc.

** Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note I: Tissue Harmonic Imaging,

રાજ્યન

Note 2: Smart3D

Note 3: Scape

Note4: iBeam Notes: Blopsy Guidance -

Note6: Free Xros M

Note7: 4D

Prescription USE (Per 21 CFR 801.109)

.

(Division Sign-Off) Division of Radiological Devices of In Vitro Diagnostic Device Evaluation and Safety

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Mindray Co. Lt.

System : Transducer:

ndray Co. Ltd. - DC-3/DC-37 Diagnostic Ultrasound Sy

Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diagnostic Ultrasound System ୧୯୬ ।

Diagnostic uttensound Imaging or thaid flow analysis of the human body as follows: Intended Use: : - : : Clinical Application Mode of Operation General Specific Color Amplitude Combined (Track I B ਮ PWD CWD Other (specify) Doppler (Track 1 & 3) Doppler (specify) Only) Ophibalmic Opathalmic Nore2. 3,5,5 િત્તમાં ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ ું નવ P મુજ P P P Abdominal Introperative (specify)" Intraoperative (Neuro) :55 Leparoscopic Pediatric Small organ(specify) ** Neonaral Cephalic Fetal Imaging Adult Cephalic & Other Trans-rectal P P ・ト P P ಕ್ಕಿ Note2, 3,5,6 Trans-vaginal P P P P p ﻬﺎ Note2, 3,5,6 Trans-cretheal Trans-esoph (non-Card.) ... 1 ... Musculo-skeletal Conventional : Musculo-skeletal Superficial futravascular : : Other (specify) *** p P P P P 产 Note 2,3,5,6 Cardiac Adult Cardiac Pediatric Cardiac Intravascular (Cardiac) Trans-esoph (Cardiac) Intra-Cardiac 13:40 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 Peripheral Vascular ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ Peripheral ﺔ ﺍﻟﻤﺘﺤﺪﺓ Vascular Other (specify)

Nenew indication: Pepreviously cleared by FDA: E-added under Appendix E

Additional comments: Combined mades: B+M, PW+B, Calar + B, Power + B, PW +Color+ B, Power + PW +B,

• lotraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, testes, etc.

** Small organ-breast, thyroid, testes, exc.

*** Other use includes Urology.

Nate 1: Tissue Harmonic Imaging. Note 2: Smart 3D

Note 3: IScape

Note4: Besm

Notes: Blogsy Guldance

Note6: Free Xros M

Hote7: 4D

Prescription USE (Per 21 CFR 801.109)

.

(Division Sign-Off) Division of Radiological Devices Vitro Diagnostic Device Evaluation and Safety Office of In

510K K102865

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Diagnostic Ultrasound Indications for Use Form

System: DC-3/DC-3T Diagnostic Ultrasound System 7L4A Transducer: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 1. 1. 11.11.10.2 ... Clinical Application Mode of Operation General Spécific Color Amplitude Combined (Track I B PWD CWD Other (specify) ಹ (Track 1 & 3) Doppler Doppler (specify) Only) Ophthalmic - Ophthalmic Ophihalmic Fetal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Abdominal P p P Note 2,3,4,5,6 Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic . Pediatric P P P Note 2,3,4,5,6 P P P Small organ(specify) ** P a . P . P P Note 2,3,4,5,6 Fetal Neonatal Cephalic) Ne p P P p Note 2,3,4,5,6 P Imaging Adult Cephalic ...... & Other Trans-rectal . Frans-vaginal Trans-urethral Trans csoph (non-Card.) Musculo-skeletal Conventional p P Note 2,3,4,5,6 P P p - -P Musculo-skeletal Superficial P P P P P p | | || Note 2,3,4,5,6 Intravascular ....... Other (specify) *** Cardiac Adult Cardiac Pediatric Cardiac Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-Cardiac Cardiac Section . : 发出 Peripheral Peripheral Vascular P P p P : Note 2,3,4,5,6 12 Vascular Other (specify)

Nanew indication; Pepreviously cleared by FDA; E-added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B,

*Intraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, testes, etc.

*** Other use includes Urology.

Note 1: Tissue Harmonic Imaging.

Note 2: Smart3D

Note 3: iScape

Noted: IBeam

Notes: Biopsy Guidance

Note6: Free Xros M

Note7: 4D

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K102865

0033

{9}------------------------------------------------

71:6

Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diagnostic Ultrasound System

System: Transducer. Intended Use:

Diagnostic ultrasound imaging or finid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 2,3,4,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	P	Note 2,3,4,5,6
	Small organ(specify)**	P	P	P		P	P	P	Note 2,3,4,5,6
	Neonatal Cephalic	P	P	P		P	P	P	Note 2,3,4,5,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	P	Note 2,3,4,5,6
	Musculo-skeletal Superficial	P	P	P		P	P	P	Note 2,3,4,5,6
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	P	P	P		P	P	P	Note 2,3,4,5,6
	Other (specify)

18 12 12 12 12 12 12 12 12

*Intraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, lestes, etc.

*** Qther use includes Urology.

Note I: Tissue Harmonic Imaging.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

Note5: Biopsy Guidance

Note6: Free Xros M

Note7: 4D'

રાજ્યન

Prescription USE (Per 21 CFR 801 109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

0034

{10}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

IOLA

• System: Transducer:
  Intended Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3).		B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal		P	P	P		P	P	P	Note 2,3,4,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric		P	P	P		P	P	P	Note 2,3,4,5,6
	Small organ(specify)**		P	P	P		P	P	P	Note 2,3,4,5,6
	Neonatal Cephalic		P	P	P		P	P	P	Note 2,3,4,5,6
FetalImaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional		P	P	P		P	P	P	Note 2,3,4,5,6
	Musculo-skeletal Superficial		P	P	P		P	P	P	Note 2,3,4,5,6
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular		P	P	P		P	P	P	Note 2,3,4,5,6
Vascular	Other (specify)

under Appendix E A cleared of the C.

Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW+B.

• Intraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, testes, etc. ** · Other use includes Urology.

610H

ther than anhydrous C(ClO4)4.

Note 1: Tissue Harmonic Imaging. Note 2: Smart3D

• Note 3: iScape
• -Note4: iBeam

NoteS: Biopsy Guidance

Nate6: Free Xros M

• Note7: 4D
  Presenption USE (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

DC-3/DC-3T Disgnostic Ultrasound System

{11}------------------------------------------------

6C2

Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diagnostic Ultrasound System

System: Transducer; Intended Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows;

Clinical Application		Mode of Operation							Other (specify)
General(Track I Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 2, 3,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 2, 3,5,6
	Small organ(specify)**
	Neonatal Cephalic	P	P	P		P	P	P	Note 2, 3,5,6
	Adult Cephalic	P	P	P		P	P	P	Note 2, 3,5,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***	P	P	P		P	P	P	Note 2, 3,5,6
Cardiac	Cardiac Adult	P	P	P		P	P	P	Note 2, 3,5,6
	Cardiac Pediatric	P	P	P		P	P	P	Note 2, 3,5,6
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular
	Other (specify)

Nenew indication; Pepreviously cleared by FDA; E=added under Appendix E

Addlikanal comments: Combined modes: 8+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B

• Intraoperative includes stidominal, thoracic, and vascular etc.

• ** Small organ-breast, thyroid, testes, etc. *** Other use includes Urology.
• Note 1: Tissue Harmonic Imaging.
• Note 2: Smart3D
• Note 3: iScape
• Note4: IBeam
• Notes: Biopsy Guidance Noteb: Free Xros M
• Note7: 4D

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Dieggaesia Dai

Office of In Vitro Diagnostic Device Evaluation and Safety

iption USE (Per 21 CFR 801.109

{12}------------------------------------------------

DC-3T Diagnostic Ultrasound System

Diagnostic Ultrasound Indications for Use Form

.

System: Transducer: DC-3/DC-3T Diagnostic Ultrasound System 6LE7

Intended Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

Clinical Application	Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal	P	P	P		P	P	P	Note 2,3,4,5,6
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small organ(specify)**
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 2,3,4,5,6
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***	P	P	P		P	P	P	Note 2,3,4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular
	Other (specify)

Nenew indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

• Intraoperative includes abdominal, thoracic, and vascular etc.

• Small organ-breast, thyroid, testes, etc.

***Other use includes Urology. Note 1; Tissue Harmonic Imaging.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

Note7: 4D

Note5: Biopsy Guidance

Note6: Free Xros M

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K102865

(Division Sign-Off)
Division of Radiological Devices

Prescription USE (Per 21 CFR

{13}------------------------------------------------

3-3T Diagnostic Ultrasound System

Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diegnostic Ultrasound System

• System: Transducer:
  Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: : :

1. 2 .. 1 :

&&&

Clinical Application		Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small organ(specify)**
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 2,3,4,5,6
	Trans-vaginal
	Trans-urethral
	Trans-esoph (non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***	P	P	P		P	P	P	Note 2,3,4,5,6
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular
	Other (specify)

Additional comments: Combined modes: B+M, PW+B, Color +B, Power + B, PW +Color+ B, Power +

• Intraoperative includes abdominal, thoracic, and vascular etc.

• ** Small organ-breast, thyroid, lestes, etc.
• *** Other use includes Urology.

Note I: Tissue Harmonic Imaging,

• Note 2: Smart3D
• Note 3: iScape
• Note4: iBeam Note5, Biopsy Guidan Note6: Free Xros M Note7: 4D

(Division Sign-Off)
Division of Radiological Devices

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102865

{14}------------------------------------------------

DC-3/DC-3T Diagnostic Ultrasound System

Diagnostic Ultrasound Indications for Use Form

stem: ransducer Intended Use: DC-3/DC-3T Diagnostic Ultrasound System

3Ci Diagnostic ultrasound imaging or fluid flow analysis of the human body as foll

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,3,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,5,6
	Small organ (specify)**
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult	P	P	P		P	P	P	Note 1,2,3,5,6
	Cardiac Pediatric	P	P	P		P	P	P	Note 1,2,3,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular
	Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

dditional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.

·Intraoperative includes abdominal, thoracie, and vascular etc.

• ** Small organ-breast, thyroid, testes, etc.
• ***Other use includes Urology,
• Note I: Tissue Harmonic Imaging.
• Note 2: Smart3D
• Note 3: iScape
• Note4: iBeam Note5: Biopsy Guidane
• Note6: Free Xros M
• Note7: 4D

(Division Slan-Off) on of Redictorical Devices Diagnostic Device Evaluation and Safety office of In

{15}------------------------------------------------

Ltd. - DC-3/DC-3T Diagnostic Ultrasound System indrav Co.

DC-3/DC-3T Diagnostic Ultrasound System System 2P2 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: : Clinical Application Mode of Operation Specific General Color Amplitudé Combined B CWD િ PWD Other (specify) (Track I Only) (Track I & 3) Doppler Doppier (specify) Ophihalmic Ophthalmic Feial Abdominal ﻴﺔ P P P ﻠﻘﺔ P b Note 1, 2,5,6 Intraoperative (specify)* ... ... ... SESS OF Intraoperative (Neuro) 的一个 ... Laparoscopic Scopic Laparato ਸੁਲਮ ( Pediatric . . . P P P b P P b Note 1, 2,5,6 + Small organ(specify) ** Note 1, 2,5,6 Neonatal Cephalic P P P P P P P Fetel Imaging Adult Cephalic P P P P P P Note 1, 2,5,6 P & Other Trans-rectal : Trans-vaginal Trans-urethral Trans-esoph, (non-Card.) 11 Musculo-skeletal Conventional -----Musculo-skeletal Superficial Intravascular . . . . . . . . . . . . . . . Other (specify)*** Cardiac Adult P P P P P Note 1, 2,5,6 P P Cardiac Pediatric b ార్ల b મુજ b P P Note 1, 2,5,6 Cardiac Intravascular (Cardiae) an mas Trans-esoph (Cardiac) :" Intra-Cardiac : : : : : Peripheral Vascular erioheral . Va Other (specify) ...... :

Diagnostic Ultrasound Indications for Use Form

Nenew indication; Pepreviously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M, PW+B, Color + B, PW: +Color+ B, PW: +Color+ B, Power + PW+B.

• Intraoperative includes abdominal, thoracic, and vascular etc.

• Small organ-breast, thyroid, testes, etc.
• ** Other use includes Urology.
• Note i: Tissue Harmonic Imaging.
• Note 2: Smart BD
• Note 3: iScape
• Note4: iBesm
• Notes : Biopsy Guidance Nate6: Free Xros M
• Nate7: 4D

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102865

{16}------------------------------------------------

DC-3/DC-3T Diagnostic Ultrasound System indray Co. Ltd. -

Diagnostic Ultrasound Indications for Use Form

System: Transducer: DC-3/DC-3T Diagnostic Ultrasound System 7LS ...

Intended Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

	Clinical Application		Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 2,3,4,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 2,3,4,5,6
	Small organ(specify)**	P	P	P		P	P	P	Note 2,3,4,5,6
	Neonatal Cephalic	P	P	P		P	P	P	Note 2,3,4,5,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	P	Note 2,3,4,5,6
	Musculo-skeletal Superficial	P	P	P		P	P	P	Note 2,3,4,5,6
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	P	P	P		P	P	P	Note 2,3,4,5,6
	Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Calor + B, Power + PW +B.

• . Intraoperative includes abdominal, thoracic, and vascular etc.
• ** Small organ-breast, thyroid, testes, etc. . ***Other use includes Urology.
• Note I: Tissue Harmonic Imaging.
• Note 2: Smart3D
• Note 3: iScape
• Note4: iBeam
• Note5: Biopsy Guidance
• Note6: Free Kros M
• Note7: 4D

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K102865

{17}------------------------------------------------

DC-3/DC-3T Diagnostic Ultrasound indray Co.

Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diagnostic Ultrasound System 7LT4

Transducer: Intended Use.

System:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application	Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	8	હત	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other Ispecif
Ophthalmic	Ophthalmic Open		ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ	11 11 22 22					presente of
	Fetal Fill2020 8:52 2017 20:			. Sash .
	Abdominal	P	ﺮ ﺍﻟﻤﺴﺎﻫﻤﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ	1 8		ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ	P	P	Note 2,3,4,5,6
	Intraoperative {specify)*	P	P	P		p	P	p	Note 2,3,4,5,6
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric :: :	P	P	P		P	P	12	Note 2,3,4,5,6
	Small organ(specify)**	a	. P	P		p	.	P	Note 2,3,4,5,6
Feul	Neonatal Cephalic	P	ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ	P		P	a parti		Note 2,3,4,5,6
Imaging& Other	Adult Cephalic		11:22:1	ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
	Trans-rectal Section
	Trans-vaginal
	Trans-urethral
	Trans-esoph (non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	P	Note 2,3,4,5,6
	Musculo-skeletal Superficial	P	- P	P		P	. 2	P	Note 2,3,4,5,6
	Intravascular
	Other (specify) ***						: 2018年1		1 3 3 3 3 1 1 8 - 2 3 1 1 3
	Cardiac Adult	P P BE		P			and police	. . P	Note 2,3,4,5,6
	Cardiac Pediatric	P		a p		P	P		Note 2,3,4,5,6
Cardinc	Intravascular (Cardiac)
	Trans-esoph (Cardiac)
	Intra-Cardiac
Peripheril	Peripheral Vascular	P	P	P		P	P	P	Note 2,3,4,5,6
Vascular	Other (specify)

N=new indication; Pepreviously cleared by FDA: Ewadded under Appendix E

Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color + B, PW +Color+ B, Po

· Intraoperative includes abdominal, thoracic, and vascular etc.

• ** Small organ-breast, thyroid, testes, etc.
• ***Other use includes Urology.
• Note I: Tissue Harmonic Imaging.
• Note 2: Smart3D
• Note 3: iScape Note4: iBeam
• Note5: Biopsy Guidance Note6: Free Xros M
• Note7: 4D

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Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K102865

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{18}------------------------------------------------

D6-2

Diagnostic Ultrasound Indications for Use Form

System:

DC-3/DC-3T Diagnostic Ultrasound System

• Transducer: latended Use:
  Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Clinical Application			Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
	Ophthalmic Ophthalmic
FetalImaging& Other	Fetal	P	P	P		P	P	P	Note 1, 2, 3,6,7
	Abdominal	P	P	P		P	P	P	Note 1, 2, 3,6,7
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1, 2, 3,6,7
	Small organ(specify)**
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular
	Other (specify)

: 上一篇: 上一篇: ditional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW

*Intraoperative includes abdominal, thoracic, and vascular etc.

• ** Small organ-breast, thytoid, testes, etc.
  *** Other use includes Urology.

Note I: Tissue Harmonic Imaging.

• Note 2: Smart3D
  Note 3: iScape

Noted: iBeam Note5 : Blopsy Guidance

Note6: Free Xros M

Note 7: 4D

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510K K102865

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.